NCT06314685

Immunogenicity and Safety of MCV4 in Volunteers Aged 6 Months-5 Years

A Single-center, Randomized, Blind, Positive Control Phase III Clinical Trial to Evaluate Immunogenicity and Safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in Healthy Volunteers Aged From 6 Months to 5 Years

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,450 (actual)
• Sponsor: Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the immunogenicity and safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old.

Detailed description

This is a Phase III, single center, randomized, blind, positive control clinical trial conducted in Hunan Province, China. The purpose of this study is to evaluate the immunogenicity and safety of Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine in healthy volunteers aged from 3 months to 5 years old. A total of 2450 subjects were included, divided into three age groups: 6-11 months old (700 subjects), 12-23 months old (1050 subjects), and 2-5 years old (700 subjects).

Conditions

• Healthy Population

Interventions

Type	Name	Description
BIOLOGICAL	Group ACYW135 Meningococcal Polysaccharide Conjugate Vaccine	As a experimental vaccine for 6 months to 5 years old.
BIOLOGICAL	Group A and C Meningococcal Polysaccharide Vaccine	As a control vaccine for ages 6-11 months and 12-23 months.
BIOLOGICAL	Group ACYW135 Meningococcal Polysaccharide Vaccine	As a control vaccine for ages 2-5 years.

Timeline

• Start date: 2021-12-10
• Primary completion: 2024-08-30
• Completion: 2024-08-30
• First posted: 2024-03-18
• Last updated: 2024-04-03

Locations

1 site across 1 country: China